Culturing microorganisms found in bodily fluids, including urine, to determine an illness is known in the art. Originally, such culturing was carried out in laboratories by collecting urine from a patient in a collection container, dipping a transfer utensil into the urine in the cup, streaking a culture medium in a Petri dish with the dipped transfer utensil, and then incubating the dish for a predetermined amount of time. After incubation, microbial colonies appeared on the medium and qualitative and quantitative results were determined.
Currently, dipslides are used for culturing urine samples in laboratory and non-laboratory settings, the latter including doctors' offices or medical clinics. Dipslides are culture (growth) medium coated, generally paddle-like, supports which are dipped directly into the urine collected in a collection container. Typically the paddle is coated with a different culture medium on each of its two sides; it comes with a container and stopper into which it fits during incubation after it has been dipped into the urine. The dipslides are typically incubated at the sample collection site, typically at about body temperature 37° C. Culturing generally requires that the stopper not be tightly sealed so that air can enter allowing for the growth of aerobic microorganisms. After initial incubation at the sample collection site, the dipslides are sent to a clinical laboratory for further incubation. If the results of culturing are negative, nothing further is done. If the results are positive, the dipslide is touched by a transfer utensil which in turn is used to streak agar in a Petri dish. The dish is then incubated at the laboratory, and, after a sufficient incubation period, examined to verify the previous positive results.
Dipslides are produced by many producers such as Oxoid Ltd., Basingstoke UK and Accepta Ltd., Manchester, UK. Several variants of dipslides are available, such as the Diaslide™ and Dipstreak™ produced by NovaMed Ltd. of Jerusalem Israel. These operate essentially in the same way as the simpler dipslides but with slight variations. In all cases, a urine collection container containing urine must be opened and the culture (growth) medium coated paddle must be dipped directly into the open container. After withdrawing the paddle, it is placed in a test tube and incubation is begun on-site. The whole process is performed by personnel not necessarily trained in handling potentially bio-hazardous materials, such as may be present in the urine.
Urinalysis today is done in a manner very similar to microbial culturing of urine discussed above. Urine is collected from the patient in a sample collection vessel. A test strip impregnated or coated with one or more reagents that react with one or more components often found in urine is dipped into the collection vessel. Changes in the reagent coated strip are then noted either visually or instrumentally. Typical urine test strips for use in urinalysis are manufactured by Roche Diagnostics, Basel, Switzerland, Bayer Corporation, Tarrytown, N.Y., (Multistix®) and Dialab GmbH, Vienna, Austria. Typical instrumental analyzers for reading dipped urine test strips are manufactured, for example, by Greiner Bio-One GmbH, Kremsmunster, Austria and Roche Diagnostics, Basel, Switzerland.
The problems with this type of urinalysis are similar to those encountered when culturing uropathogens as described above. A collection cup containing a potentially bio-hazardous liquid, urine, must be opened and a urine test strip must be dipped by a member of the medical staff or a laboratory technician into the liquid. In the case of urinalysis, instruments used for reading the urine test strip must be cleaned often since there is direct contact between the dipped test strip and the electronic reader and other parts of the instrument. When visually reading a urine test strip, the strip is compared to a chart provided by the manufacturer typically positioned on the bottle in which the strips are sold. Often, when comparing the color of the strips to the colors on the chart, the strip is brought near to the chart actually touching it. This allows for the spread of pathogenic organisms.
In view of the above, it would be advantageous to develop a closed system for microbial culturing and/or analysis of bodily fluids which reduces the dangers of contamination. Additionally, it would be advantageous to develop a closed system, which persons not necessarily trained in microbiological procedures could use without increasing the attendant health risks to them. There is also a need for a product that would allow dipslides to be sent for further testing in laboratory settings without escape of the liquid from the container and without it rewetting the medium coated paddle. It would also be advantageous to develop a system that is disposable and low cost.